GenBody America’s COVID-19 antigen test kits are now authorised for use by the Food and Drug Administration (FDA) for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Recently, the company received an amendment to its original Emergency Use Authorisation (EUA) by the FDA allowing for the company’s visually readable COVID-19 antigen test kit for use with anterior nasal swabs.
The FDA Letter of Authorization states: “The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.”
According to the FDA, “serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission.”
GenBody sells and distributes direct nasopharyngeal and anterior nasal swab antigen tests intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. The tests are authorised for use at the point of care, i.e., in-patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
David Yoo, CEO of GenBody America, said: “This new ‘claim’ allows CLIA-waived laboratories to use GenBody test kits to test individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. The median incubation period for coronavirus disease 2019 (COVID-19) is approximately five days, according to study results published in medRxiv. Serial testing allows CLIA-waived laboratories to test individuals without symptoms to catch a wider spectrum of the course of the disease when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.”
In March, the FDA issued a new supplemental template “for test developers seeking emergency use authorisation (EUA) of certain tests for screening with serial testing. This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. As part of this new template for test developers, the agency provided recommendations aimed to streamline the authorisation of screening tests with serial testing.”
GenBody was awarded a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative award of $10 million in support of U.S. production of GenBody's innovative point of care tests that will increase the testing capacity in the U.S.
